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A randomised controlled trial to examine the effects of cinacalcet on bone and cardiovascular parameters in haemodialysis patients with advanced secondary hyperparathyroidism.
Eddington, H, Chinnadurai, R, Alderson, H, Ibrahim, ST, Chrysochou, C, Green, D, Erekosima, I, Hutchison, A, Bubtana, A, Hegarty, J, et al
BMC nephrology. 2021;(1):106
Abstract
BACKGROUND Secondary hyperparathyroidism may lead to increased cardiovascular risk. The use of cinacalcet may improve bone and cardiovascular health with improved parathormone (PTH) and phosphate control. METHODS This is an open-label prospective randomised controlled trial to compare progression of cardiovascular and chronic kidney disease mineral and bone disorder (CKD-MBD) parameters. Patients were randomised to receive cinacalcet alongside standard therapy or standard therapy alone. Thirty-six haemodialysis patients who had > 90 days on dialysis, iPTH > 300 pg/mL, calcium > 2.1 mmol/L and age 18-75 years were included. Following randomization, all 36 patients underwent an intensive 12-week period of bone disease management aiming for iPTH 150-300 pg/mL. The primary outcome was change in vascular calcification using CT agatston score. Secondary outcomes included pulse wave velocity (PWV), left ventricular mass index (LVMI), carotid intima-media thickness (CIMT), augmentation index (Aix) and bone measurements. The above measurements were obtained at baseline and 12 months. RESULTS There was no evidence of a group difference in the progression of calcification (median change (IQR) cinacalcet: 488 (0 to1539); standard therapy: 563 (50 to 1214)). In a post hoc analysis combining groups there was a mean (SD) phosphate reduction of 0.3 mmol/L (0.7) and median (IQR) iPTH reduction of 380 pg/mL (- 754, 120). Regression of LVMI and CIMT was seen (P = 0.03 and P = 0.001) and was significantly associated with change of phosphate on multi-factorial analyses. CONCLUSIONS With a policy of intense CKD-MBD parameter control, no significant benefit in bone and cardiovascular markers was seen with the addition of cinacalcet to standard therapy over one year. Tight control of hyperphosphataemia and secondary hyperparathyroidism may lead to a reduction in LVMI and CIMT but this needs further investigation. Although the sample size was small, meticulous trial supervision resulted in very few protocol deviations with therapy.
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Arnica compositum, Hekla lava and Acidum Nitricum Together are Superior to Arnica compositum Alone in the Local Treatment of Symptomatic Calcific Periarthritis of the Shoulder: A Pilot Study.
Zanella, S, Buccelletti, F, Franceschi, F, Ramponi, C, Spagnolli, F, Sacchetti, G, Oliva, G, Lumachi, F
Reviews on recent clinical trials. 2018;(2):150-155
Abstract
BACKGROUND To evaluate the usefulness of Arnica compositum (AC) + Acidum nitricum (AN) + Hekla lava (HL) ointment in Emergency Medicine Department (EMD) as alternative nonpharmacological local treatment of patients with symptomatic calcific periarthritis of the shoulder (CPS) and to compare the effectiveness of this mixture against AC ointment alone. METHODS A series of 41 consecutive patients (20 women, 19 men, median age 49 years, range 25-80 years) with non-traumatic painful unilateral CPS were randomly assigned to receive local treatment with AC+AN+HL ointment mixture (Group A, cases, N=21) or AC ointment alone (Group B, controls, N=20). The radiological Gartner classification of the CPS, and the quantification of pre- and post-treatment pain intensity using a Visual Analogue Scale (VAS) were obtained. The orthopedic evaluation of Shoulder Motion (SM) was also performed. The use of painkillers was reported as a number of doses needed. RESULTS Age, gender distribution, Gartner type, main calcification size, baseline VAS (VAS-0) and degree of SM did not differ (p=NS) between Groups. After 3-day therapy, the reduction of pain in Group A (4.5±2.5) was superior to that observed in Group B (2.7±2.6) (p =0.03). The same result was observed in the improvement of SM in Group A (69.4±24.9) than in Group B (51.1±21.1) (p =0.015). No local or general adverse effects were noted. The number of doses of paracetamol was similar, but Group A patients used less ibuprofen (p =0.007). CONCLUSION Local administration of the AC+AN+HL ointment mixture, which in our pilot study was superior to AC alone, could be safely suggested as an alternative uneventful treatment of patients with CPS.
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Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial.
Achenbach, S, Paul, JF, Laurent, F, Becker, HC, Rengo, M, Caudron, J, Leschka, S, Vignaux, O, Knobloch, G, Benea, G, et al
European radiology. 2017;(2):821-830
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Abstract
OBJECTIVES To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. METHODS In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. RESULTS Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. CONCLUSIONS With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. KEY POINTS • Iodine concentration is an important parameter for image quality in coronary CTA. • Contrast enhancement must be balanced against the amount of iodine injected. • Iobitridol 350 is non-inferior compared to CM with higher iodine concentrations. • Higher attenuation with higher iodine concentrations, but no SNR or CNR differences.
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Blood Calcification Propensity, Cardiovascular Events, and Survival in Patients Receiving Hemodialysis in the EVOLVE Trial.
Pasch, A, Block, GA, Bachtler, M, Smith, ER, Jahnen-Dechent, W, Arampatzis, S, Chertow, GM, Parfrey, P, Ma, X, Floege, J
Clinical journal of the American Society of Nephrology : CJASN. 2017;(2):315-322
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BACKGROUND AND OBJECTIVES Patients receiving hemodialysis are at risk of cardiovascular events. A novel blood test (T50 test) determines the individual calcification propensity of blood. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS T50 was determined in 2785 baseline serum samples of patients receiving hemodialysis enrolled in the Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events (EVOLVE) trial and the T50 results were related to patient outcomes. RESULTS Serum albumin, bicarbonate, HDL cholesterol, and creatinine were the main factors positively/directly and phosphate was the main factor negatively/inversely associated with T50. The primary composite end point (all-cause mortality, myocardial infarction [MI], hospitalization for unstable angina, heart failure, or peripheral vascular event [PVE]) was reached in 1350 patients after a median follow-up time of 619 days. After adjustments for confounding, a lower T50 was independently associated with a higher risk of the primary composite end point as a continuous measure (hazard ratio [HR] per 1 SD lower T50, 1.15; 95% confidence interval [95% CI], 1.08 to 1.22; P<0.001). Furthermore, lower T50 was associated with a higher risk in all-cause mortality (HR per 1 SD lower T50, 1.10; 95% CI, 1.02 to 1.17; P=0.001), MI (HR per 1 SD lower T50, 1.38; 95% CI, 1.19 to 1.60; P<0.001), and PVE (HR per 1 SD lower T50, 1.22; 95% CI, 1.05 to 1.42; P=0.01). T50 improved risk prediction (integrated discrimination improvement and net reclassification improvement, P<0.001 and P=0.001) of the primary composite end point. CONCLUSIONS Blood calcification propensity was independently associated with the primary composite end point, all-cause mortality, MI, and PVE in the EVOLVE study and improved risk prediction. Prospective trials should clarify whether T50-guided therapies improve outcomes.
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Effect of Statins on the Progression of Coronary Calcification in Kidney Transplant Recipients.
Yazbek, DC, de Carvalho, AB, Barros, CS, Medina Pestana, JO, Canziani, ME
PloS one. 2016;(4):e0151797
Abstract
BACKGROUND Coronary calcification (CAC) is highly prevalent in kidney transplant recipients (KTRs) and has been associated with cardiovascular morbidity and mortality. Some studies have shown a reduction in CAC progression with statin therapy in the general and chronic kidney disease (CKD) populations. OBJECTIVES AND METHODS The aim of the present study was to evaluate the effect of statins on CAC progression in incident kidney transplant recipients. Patients were randomly assigned to the statin (n = 61, 10 mg daily) and control group (n = 59). CAC and biochemical analyses were performed at baseline and 12 months. RESULTS At baseline, CAC was observed in 30% and 21% of patients in the statin and control groups, respectively (p = 0.39). The calcium score at baseline and its absolute and relative changes over 12 months of follow up were similar among the groups. In the statin group, total cholesterol (p < 0.001), low density lipoprotein cholesterol (p < 0.001) and triglycerides (p = 0.005) decreased, and the estimated glomerular function rate increased (p<0.001) significantly. CRP levels remained stable (p = 0.52) in the statin group but increased in the control group (p = 0.01). In the multivariate model, there was no difference in CAC progression between the groups (group effect p = 0.034; time-effect p = 0.23; interaction p = 0.74). Similar results were obtained when only patients with ≥ 10AU calcium score (calcified) were analyzed (group effect p = 0.051; time-effect p = 0.58; interaction p = 0.99). CONCLUSION Although statins reduce the levels of cholesterol, triglycerides, inflammation and improve graft function, the dose adopted in the current study did not delay CAC progression within 12 months of follow up. TRIAL REGISTRATION Brazilian Clinical Trials Registry RBR-32RFMB.
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Coronary artery calcification detected in lung cancer screening predicts cardiovascular death.
Rasmussen, T, Køber, L, Abdulla, J, Pedersen, JH, Wille, MM, Dirksen, A, Kofoed, KF
Scandinavian cardiovascular journal : SCJ. 2015;(3):159-67
Abstract
OBJECTIVES It remains unknown whether non-electrocardiogram-gated coronary artery calcium (CAC) score in lung cancer screening provides incremental prognostic value. The aim of this study was to evaluate the prognostic value of CAC in the Danish Lung Cancer Screening Trial (DLCST), in addition to conducting a systematic review and meta-analysis including previously published studies regarding CAC in lung cancer screening. DESIGN In DLCST, we measured Agatston CAC scores in 1,945 current and former smokers. Causes of death were extracted from the Danish National Death Registry. We used Cox proportional hazards model to determine hazard ratios (HRs) of CAC scores. A weighted fixed-effects model was used for the meta-analysis. RESULTS Median follow-up in DLCST was 7.1 years, and 55% were men. Overall survival rates associated with CAC scores of 0, 1-400, and > 400 were 98%, 96%, and 92% (p < 0.001), respectively. Adjusted HR of cardiovascular death associated with CAC >400 was 3.8 (1.0-15) (p < 0.05). The meta-analysis included 28,045 asymptomatic participants. A high non-gated CAC score was associated with fatal or non-fatal cardiovascular events (p < 0.0001). CONCLUSION Assessment of non-electrocardiogram-gated CAC in lung cancer screening programs is a robust prognostic measure of fatal or non-fatal cardiovascular events in current and former smokers independent of traditional cardiovascular risk factors.
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Which method is more effective in treatment of calcific tendinitis in the shoulder? Prospective randomized comparison between ultrasound-guided needling and extracorporeal shock wave therapy.
Kim, YS, Lee, HJ, Kim, YV, Kong, CG
Journal of shoulder and elbow surgery. 2014;(11):1640-6
Abstract
HYPOTHESIS Ultrasound (US)-guided needling with subacromial corticosteroid injection is more effective than extracorporeal shock wave therapy (ESWT) for function restoration and pain relief in patients with calcific tendinitis of the shoulder. METHODS Fifty-four patients diagnosed with unilateral painful calcific tendinitis were randomly allocated to a US needling or ESWT group. The US needling group underwent US-guided needling and received a subacromial corticosteroid injection. The ESWT group received ESWT 3 times a week. All patients were prospectively evaluated; American Shoulder and Elbow Surgeons, Simple Shoulder Test, and visual analog scale for pain scores were recorded before the procedure and at 6 weeks, 12 weeks, 6 months, 12 months, and the last follow-up. The size and morphology of the deposits were evaluated by radiography. RESULTS The average follow-up period was 23.0 months. At last follow-up, the mean size of the deposits was significantly different between the 2 groups (P = .001); it decreased to 0.5 mm from 14.8 mm in the US needling group and to 5.6 mm from 11.0 mm in the ESWT group. There were also significant improvements in clinical outcomes in both groups after treatment (P < .05). At 1-year follow-up, the US needling group had significantly better scores than the ESWT group with regard to the American Shoulder and Elbow Surgeons assessment (90.3 and 74.6, respectively; P = .001), Simple Shoulder Test (83.3 and 70.8, respectively; P = .015), and visual analog scale for pain (1.4 and 3.3, respectively; P = .003).The initial calcium deposit sizes and clinical outcomes were weakly correlated in both groups (P > .05). CONCLUSION Both treatment modalities for calcific tendinitis improved clinical outcomes and eliminated calcium deposits. US-guided needling treatment, however, was more effective in function restoration and pain relief in the short term.
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Impact of iterative reconstruction on CT coronary calcium quantification.
Kurata, A, Dharampal, A, Dedic, A, de Feyter, PJ, Krestin, GP, Dijkshoorn, ML, Nieman, K
European radiology. 2013;(12):3246-52
Abstract
OBJECTIVES We evaluated the influence of sinogram-affirmed iterative reconstruction (SAFIRE) on the coronary artery calcium (CAC) score by computed tomography (CT). MATERIALS AND METHODS Seventy patients underwent CAC imaging by 128-slice dual-source CT. CAC volume, mass and Agatston score were calculated from images reconstructed by filtered back projection (FBP) without and with incremental degrees of the SAFIRE algorithm (10-50 %). We used the repeated measuring test and the Steel-Dwass test for multiple comparisons of values and the difference ratio among different SAFIRE groups using the FBP as reference. RESULTS The median Agatston score (range) decreased with incremental SAFIRE degrees: 163 (0.1 - 3,393.3), 158.4 (0.3 - 3,079.3), 137.7 (0.1 - 2,978.0), 120.6 (0 - 2,783.6), 102.6 (0 - 2,468.4) and 84.1 (0 - 2,186.9) for 0 % (FBP), 10 %, 20 %, 30 %, 40 % and 50 % SAFIRE, respectively (P < 0.05). In comparison with FBP, CAC volume (from 8.1 % to 47.7 %), CAC mass (from 5.3 % to 44.7 %) and CAC Agatston score (from 7.3 % to 48.4 %) all decreased with increasing SAFIRE from 10 % to 50 %, respectively (P < 0.05). High-grade SAFIRE resulted in the disappearance of detectable calcium in three cases with low calcium burden. CONCLUSION SAFIRE noise reduction techniques significantly affected the CAC, which potentially alters perceived cardiovascular risk.
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Spotty calcification as a marker of accelerated progression of coronary atherosclerosis: insights from serial intravascular ultrasound.
Kataoka, Y, Wolski, K, Uno, K, Puri, R, Tuzcu, EM, Nissen, SE, Nicholls, SJ
Journal of the American College of Cardiology. 2012;(18):1592-7
Abstract
OBJECTIVES The purpose of this study was to determine atheroma progression in patients with spotty calcification. BACKGROUND Although extensively calcified atherosclerotic lesions have been proposed to be clinically quiescent, the presence of spotty calcification within plaque has been reported to be associated with an increased incidence of ischemic cardiovascular events. The relationship between spotty calcification and disease progression has not been investigated. METHODS A total of 1,347 stable patients with angiographic coronary artery disease underwent serial evaluation of atheroma burden with intravascular ultrasound imaging. Patients with spotty calcification were identified based on the presence of lesions (1 to 4 mm in length) containing an arc of calcification of <90°. Clinical characteristics and disease progression were compared between patients with spotty calcification (n = 922) and those with no calcification (n = 425). RESULTS Patients with spotty calcification were older (age 56 years vs. 54 years; p = 0.001), more likely to be male (68% vs. 54%; p = 0.01), and have a history of diabetes mellitus (30% vs. 24%; p = 0.01) and myocardial infarction (28% vs. 20%; p = 0.004), and have lower on-treatment high-density lipoprotein cholesterol levels (48 ± 16 mg/dl vs. 51 ± 17 mg/dl; p = 0.001). Patients with spotty calcification demonstrated a greater percent atheroma volume (PAV) (36.0 ± 7.6% vs. 29.0 ± 8.5%; p < 0.001) and total atheroma volume (174.6 ± 71.9 mm(3) vs. 133.9 ± 64.9 mm(3); p < 0.001). On serial evaluation, spotty calcification was associated with greater progression of PAV (+0.43 ± 0.07% vs. +0.02 ± 0.11%; p = 0.002). Although intensive low-density lipoprotein cholesterol and blood pressure lowering therapy slowed disease progression, these efficacies were attenuated in patients with spotty calcification. CONCLUSIONS The presence of spotty calcification is associated with more extensive and diffuse coronary atherosclerosis and accelerated disease progression despite use of medical therapies.
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Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: a randomized clinical trial comparing two different energy levels.
Ioppolo, F, Tattoli, M, Di Sante, L, Attanasi, C, Venditto, T, Servidio, M, Cacchio, A, Santilli, V
Physical therapy. 2012;(11):1376-85
Abstract
BACKGROUND Extracorporeal shock-wave therapy (ESWT) represents a valid intervention in the treatment of people with supraspinatus calcifying tendinitis (SCT), but there is limited evidence for the useful range of ESWT doses. OBJECTIVE The aim of this study was to compare 2 different ranges of energy flux density in treatment of SCT with ESWT. DESIGN This study was designed as a single-blind randomized clinical trial. SETTING This study was performed in a university hospital. PATIENTS Forty-six patients with SCT were randomly assigned to 2 groups that received different therapeutic energy doses of ESWT (1) group A received ESWT at an energy level of 0.20 mJ/mm², and (2) group B received ESWT at an energy level of 0.10 mJ/mm². INTERVENTION The treatment protocol consisted of 4 sessions performed once a week. MEASUREMENTS The change in mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint. The change in the mean visual analog scale (VAS) scores from baseline to 3 and 6 months after the intervention and radiographic change in size of calcium deposits were evaluated as secondary endpoints. At 12 months, pain relief was assessed using a numeric rating scale. RESULTS Significant clinical improvement based on mean CMS scores was observed after 6 months in group A (X=79.43, SD=10.33) compared with group B (X=57.91, SD=6.53). Likewise, after 6 months, a significant decrease in VAS scores was found in group A (X=2.09, SD=1.54) compared with group B (X=5.36, SD=0.78). Calcific deposits disappeared in the same percentage of patients in both groups. LIMITATIONS The small sample size and lack of a control group were limitations of the study. CONCLUSIONS In ESWT for SCT, an energy level of 0.20 mJ/mm² appears to be more effective than an energy level of 0.10 mJ/mm² in pain relief and functional improvement.